Tissue repair device and method

ABSTRACT

A surgical device is provided. The surgical device includes a housing adapted for mounting on a finger of a user; and at least one guide tube attached along a length of the housing. The guide tube is configured for guiding a tissue repair implant from a proximal opening to a distal opening thereof.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to a device and method for guiding andanchoring an implant to a tissue. Embodiments of the present inventionrelate to a device and method for guiding and anchoring a suture, sutureanchor or mesh in a sacrospinous ligament for the purpose of repairing apelvic floor disorder pelvic organ prolapse (POP).

Trans-vaginal pelvic floor repair is a surgical procedure which utilizesblunt tissue dissection to provide access to the sacrospinous ligamentfrom the posterior vaginal wall. A sling or mesh is then anchored to thesacrospinous ligament and the vaginal apex or the uterine isthmicalfibrotic ring, cervix or body, to thereby support prolapsing tissuesand/or organs.

Although pelvic floor repair is a common procedure, access to thesacrospinous ligament is typically effected by improvised manual bluntdissection techniques and/or use of off the shelf instruments.

Centro-apical reconstruction is key for proper pelvic organ prolapse(POP) repair. The premium supportive pelvic structure is thesacrospinous ligament (SSL) which is positioned at the posterior aspectof the pelvis. The SSL is a robust ligament and thus provides a longlasting solution. Since it is positioned high in the pelvis and mediallythe SSL provides a level 1 support (DeLancey) and reduces the likelihoodof dyspareunia when utilized for prolapse repair.

Vaginal wall access to the SSL can be difficult and hazardous sinceorgans and tissues surrounding the access path can easily be injuredduring dissection. Present day approach for accessing the SSL startswith an incision at the mid-line of the posterior or anterior vaginalwall followed by lateral dissection under the sub-mucosal fascia to thepelvic side wall and dissection towards the ischial spine to the mid SSL(MSSL).

This approach decreases risk of tissue injury by bypassing thebladder/rectum while maintaining accurate navigation along the abovementioned landmarks. Such an approach requires a high degree of skilland as such can lead to a high rate of complications.

While reducing the present invention to practice, the present inventorshave developed a device which can be used to deliver a tissue anchor toanatomical landmarks and structures such as the ischial spine and thesacrospinous ligament from the vaginal cavity.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided asurgical device comprising: a housing adapted for mounting on a fingerof a user; and (b) at least one guide tube attached along a length ofthe housing, the at least one guide tube being configured for guiding atissue repair implant from a proximal opening to a distal openingthereof.

According to further features in preferred embodiments of the inventiondescribed below, the guide tube is attached to the housing such that theproximal opening protrudes beyond a proximal end of the housing.

According to still further features in the described preferredembodiments the guide tube is attached to the housing such that theproximal opening is positioned above a back of a hand of the user whenthe housing is mounted on the finger.

According to still further features in the described preferredembodiments the housing is configured so as to enable the user topalpate the tissue via the finger attached to the housing.

According to still further features in the described preferredembodiments the housing is open at a distal end thereof.

According to still further features in the described preferredembodiments the guide tube is attached to the housing such that thedistal opening abuts the tissue when the finger of the user contacts thetissue.

According to still further features in the described preferredembodiments the guide tube is attached to the housing such that thedistal opening is displaced from the tissue when the finger of the usercontacts the tissue.

According to still further features in the described preferredembodiments the suture end is attached to an anchor.

According to still further features in the described preferredembodiments the housing is configured for enabling flexion of the fingerat a distal and/or proximal interphalangeal joint.

According to still further features in the described preferredembodiments the housing is configured for attaching an imaging devicethereto.

According to still further features in the described preferredembodiments the imaging device is an ultrasound transducer.

According to still further features in the described preferredembodiments an imaging head of the ultrasound transducer is capable ofabutting the tissue when the ultrasound transducer is attached to thehousing.

According to still further features in the described preferredembodiments the imaging head abuts the tissue when the finger attachedto the housing contacts the tissue.

According to still further features in the described preferredembodiments the tissue is a posterior-lateral vaginal wall and thehousing is configured for delivery into the vaginal canal via thefinger.

According to still further features in the described preferredembodiments when the housing is positioned within the vaginal canal withthe finger in contact with the posterior-lateral vaginal wall, theproximal opening of the at least one guide tube extends out of thevaginal canal.

According to still further features in the described preferredembodiments the tissue repair implant is a mesh, a sling, a suture or asuture-anchor.

According to another aspect of the present invention there is provided amethod of repairing a pelvic floor disorder comprising: (a) positioninga surgical device via a finger within a vaginal cavity, the surgicaldevice including a housing adapted for mounting on the finger and atleast one guide tube attached along a length of the housing; (b) usingthe finger to palpate a posterior-lateral wall of the vaginal cavity andlocate a sacrospinous ligament therethrough; and (c) advancing a tissuerepair implant through the at least one guide tube and through aposterior-lateral wall to thereby anchor the tissue repair implant tothe sacrospinous ligament.

According to still further features in the described preferredembodiments the tissue repair implant is a mesh, a sling, a suture or asuture-anchor.

According to still further features in the described preferredembodiments the device further includes an ultrasound transducerattached to the housing and further wherein (b) is effected underultrasound guidance.

According to still further features in the described preferredembodiments the guide tube is attached to the housing such that aproximal opening of the guide tube is positioned outside the vaginalcavity.

According to another aspect of the present invention there is provided amethod of repairing a pelvic floor disorder comprising (a) positioning asurgical device via a finger within a vaginal cavity, the surgicaldevice including a housing adapted for mounting on the finger and atleast one guide tube attached along a length of the housing; (b) usingthe finger to palpate a posterior-lateral wall of the vaginal cavity andlocate a sacrospinous ligament therethrough; (c) advancing asuture-anchor through the at least one guide tube and through aposterior-lateral wall to thereby anchor the suture-anchor to thesacrospinous ligament; and (d) advancing a mesh over at least one suturethread of the suture-anchor; and (e) tying the at least one suturethread to secure the mesh in position.

According to another aspect of the present invention there is provided adevice for delivering a mesh to an intrabody location using a sutureanchor as a guide and the method described above. The device includes ahollow tube for accepting one or more suture threads, and a distal endfor accepting a releasable cuff attached to the mesh.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a device and method fortissue repair from within a body cavity.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIG. 1 illustrates an embodiment of the present device having a singleguide tube.

FIG. 2 illustrates an embodiment of the present device having two guidetubes.

FIG. 3 illustrates an embodiment of the present device having a singleguide tube and an imaging device.

FIG. 4 illustrates an embodiment of the present device having two guidetubes and an imaging device.

FIG. 5 illustrates the device of FIG. 1 mounted on a finger of a user.

FIGS. 6-7 illustrate insertion of the implant delivery device into theguide tube.

FIG. 8 illustrates the device of FIG. 1 mounted on a finger with theimplant delivery device positioned within the guide tube.

FIGS. 9a-h illustrate mesh delivery and securement using thesuture-anchor delivered by the present device as a guide.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of a device which can be used for tissuerepair, and specifically of a finger mounted device which can be used todeliver a tissue repair implant through a wall of a body cavity.

The principles and operation of the present invention may be betterunderstood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details set forth in the following description or exemplified bythe Examples. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein is for the purposeof description and should not be regarded as limiting.

Pelvic organ prolapse (POP), and especially apical central supportivedefect (ACSD), significantly affects the quality of life of about 20% ofthe female population.

POP is typically corrected via a transabdominal or a transvaginalsurgical procedure.

The transvaginal reconstruction approach is regarded as superior to thetransabdominal approach due to a shorter operative time and hospitalstay and quicker rehabilitation. However, transvaginal proceduresrequire advanced surgical skill and as such are performed by a rathersmall and highly qualified group of surgeons.

In the transvaginal procedure, a surgeon can elect to suspend thevaginal apex (VA) or the uterine cervix (UC) to thesacrospinous-ligament (SSL), sacrum, arcus tendineus fascia pelvis(ATFP) or other potentially solid supportive pelvic structures, whichare accessed via anterior or posterior vaginal wall incisions and bluntdissection of tissues.

Creating an access path to these tissues is a major challenge oftransvaginal procedures since it requires complicated navigation to thepelvic side wall (PSW), ischial spine (IS) and then to the mid SSL(MSSL) or the sacrum which carries with it a risk of damaging thebladder, rectum, blood vessels, nerves, ureters, etc.

Most POP procedure complications are attributed to the dissectionnecessary to create the tissue path to the elected tissue support site.

In order to traverse these limitations of prior art transvaginalprocedures, the present inventors have devised an approach whichutilizes a finger mounted intravaginal device which enables the surgeonto palpate the SSL and deliver a tissue repair implant thereto.

As used herein, the phrase “pelvic floor disorder” refers to anydisorder of the pelvic floor that is associated with prolapse,herniation or incorrect anatomical positioning of pelvic floor tissues.

Thus, according to one aspect of the present invention there is provideda device for tissue repair, and in particular, repair of pelvic floordisorders. The term “repair” when used herein with reference to pelvicfloor disorders refers to correction (complete or incomplete) ofanatomy, via, a tissue repair implant such as a suture, suture anchor,mesh, sling and/or the like.

The present device includes a housing adapted for mounting on a fingerof a user, preferably an index finger of the user. The housing can beconfigured for mounting over the finger tip or any portion of the finger(up to the distal or proximal interphalangeal joint or the entirefinger). The device further includes at least one guide tube (preferably1 or 2) attached along a length of the housing. Thus, the guide tuberuns parallel or substantially parallel to the finger of the user whenthe housing is mounted thereupon.

The housing is substantially ‘finger’-shaped (elongated slightlycompressed cylinder) with a longitudinal lumen mountable over a fingerand smooth external walls (optionally having longitudinal apertures) forfacilitating insertion of the housing into a body cavity (e.g. vaginalor anal cavity) when mounted over the finger. The distal end (away fromuser) includes an opening for the tip of the finger, such opening can becovered by an elastic this membrane.

The housing can be fabricated from a polymer or alloy (preferablybiocompatible) using molding or machining approaches. Typical dimensionsfor housing are 65 mm length, and 18 mm internal diameter. The housingincludes a finger adjusting and retaining mechanism in order to ensurethat the housing securely mounts onto a finger of any length or diameterwithout inadvertently detaching. Such a mechanism can include an elastictab mounted within the housing lumen or an adjustment mechanism foradjusting the length, height and/or width (or diameter) of the housing.One example of such a mechanism is described below with reference to theFigures.

The guide tube(s) is attached to the housing or co-fabricated therewithand is configured for guiding an implant from a proximal opening to adistal opening thereof.

The guide tube is preferably attached along a side of the housing suchthat its runs along a side of a finger (when the hand is viewed from thetop). A detailed description of one embodiment of the present device isprovided hereinbelow with reference to FIGS. 1-8.

As is mentioned hereinabove, the device of the present invention can beused for tissue repair by enabling delivery of a tissue repair implantfrom the guide tube. Such guiding can be effected with or withoutimaging guidance. When performed under imaging, the present device isconfigured for attaching an imaging device thereto. One example of animaging device is an ultrasound transducer which can be attached to adedicated bracket provided on the housing.

The present device can further include irrigation lumens for attachingan irrigation source and/or suction.

Referring now to the drawings, FIGS. 1-8 illustrate the present devicewhich is referred to herein as device 10. Device 10 is configured forintravaginal access and pelvic floor repair, however, it should be notedthat device 10 can be modified for access into other body cavities suchas the anal canal to affect repair therein or therethrough.

Device 10 includes a housing 12 which is substantially finger shaped andis 6 cm in length and 1.8 cm in diameter. Housing can be fabricated fromplastic, metal or a rubber like material. Housing 12 is configured formounting over an entire index finger (see FIG. 5) but will also providethe required functionality if configured for mounting over a portion ofthis finger. Mounting can be over a naked finger or one covered by asurgical glove. Housing 12 includes a proximal opening 14 and distalopening 16 forming lumen 18 surrounded by walls 20. Walls 20 can includeseveral apertures 22 (top aperture 22 shown) and a finger retainingmechanism 24 for elastically engaging the finger (FIG. 5) to ensure thathousing 12 is retained on a finger regardless of its dimensions. Fingerretaining mechanism 24 can be designed to accommodate any finger size byproviding an accommodative elastic force (downward) on the fingersurface. Such a force would be enough to trap the finger within housingbut would still enable a user to remove the housing by sliding it offthe finger. The diameter of the index finger distal phalanx rangesbetween 13-18 mm for most individuals and thus a single design can beused to accommodate such a finger size range.

Distal opening 16 is sized and configured to enable a tip of the fingerto protrude therethrough when housing 12 is mounted ion a finger. Thisenables a user to palpate tissue wall when device 10 is in use andpositioned within the vaginal cavity. Distal opening 16 can be coveredby a thin elastic membrane that enables palpation and yet provides abarrier between the user's finger from the tissue in cases where theuser is not wearing gloves.

Device 10 further includes at least one guide tube 28 (1 shown in FIG.1, 2 shown in FIG. 2) Guide tube can be attached to housing 12 viabrackets 29 (shown in FIGS. 1-2). Guide tube 28 is configured aselongated tube having proximal and distal openings (30 and 32respectively). Guide tube 28 has a length greater than that of housing12 such that when housing 12 is positioned within the vaginal cavity(with distal opening at or near the lateral posterior wall), proximalopening 30 is positioned outside the vaginal cavity to allow access anddelivery of a tissue repair implant therethrough (as is shown in FIGS.6-8). The length of guide tube 28 can be anywhere from 70-120 mm, whilethe outer and inner diameter can be anywhere from 2-8 mm and 1-3 mm(respectively). Guide tube 28 can be fabricated from a substantiallyrigid material such as stainless steel or from an elastic material suchas Nitinol or a polymer such as Polycarbonate. An elastic embodiment ofguide tube 28 can be advantageous in cases where the distal opening ofthe tube is not aligned with the proximal opening.

Guide tube 28 includes a port 34 for allowing a delivery device 36(shown in FIGS. 6-8) to easily access the lumen of guide tube 28.

Delivery device 36 can be constructed from two coaxial tubes. AnInternal tube attached to a tissue anchor 38 (shown in FIG. 6) and anexternal rigid tube which is coaxially disposed around the first tube.The tissue anchor 38 (which can be attached to a suture, mesh or sling)can be delivered from the rigid tube by advancing the first tubetherewithin. To effect such delivery, delivery device 36 includes ahandle 40 for actuating forward movement (in a distal direction) of thefirst tube within the rigid tube. Delivery device 36 is preferablycapable of puncturing the vaginal wall and driving tissue anchor 38through the tissue and into the target site (e.g. MSSL). As such, thedistal end of the first tube can be configured for tissue puncturing(beveled, double beveled or conical). Alternatively, tissue anchor 38can be configured for tissue puncturing or still alternatively aninitial incision in the vaginal wall can be used to deliver the firsttube therethrough. The first and rigid tubes or anchor 38 can include animaging marker for identifying these elements within an imaging plane.An example of an echogenic marker which can be used along with anultrasound probe is provided in U.S. 20050228288.

As is shown in FIG. 2, device 10 of the present invention can include 2guide tubes 28. Such a configuration allows a user to choose the bestside for delivery of a tissue repair implant or to deliver two implants.

As is shown FIG. 3, device 10 can also include an imaging device 50which is attached to housing 12 with an imaging head 52 positioned at adistal end of house 12 on a side opposite of guide tube 28 distalopening 32 or in the middle, as is shown in FIG. 4 (which depicts adevice 10 having two guide tubes 28 and an imaging device 50). Oneexample of an imaging device which can be used in device 10 is anultrasound imaging device. An ultrasound imaging device having atransducer head positioned at the distal end of housing near distalopening 32 of guide tube 28 can be used to image the SSL and surroundingstructures/organs and provide additional guidance for delivery of thetissue repair implant.

Device 10 of the present invention can be used in a pelvic organprolapse (POP) repair procedure as follows.

The site of anchoring is selected based on pre-palpation and/orpre-procedure vaginal US.

The present device is positioned on an index finger of a dominant handand a delivery device (needle) is positioned within the guide tube suchthat a distal end of the external rigid tube of the delivery device isflush with the distal opening of the guide tube.

The present device is introduced into the vaginal cavity and the indexfinger tip is used to palpate the tissue target through the vaginalwall. The external rigid tube of the delivery device is then pressedagainst the vaginal wall at the region of the ligament.

The internal tube of the delivery device is then actuated via thedelivery button of the handle to deliver the anchor through the vaginalwall and into the ligament. The internal tube is then withdrawn leavingthe anchor and attached suture/mesh in position. The suture end(s) aresecured outside the vaginal cavity via forceps and the initial pull outforce is verified by manually pulling on the suture ends. Optionally,the procedure is then repeated for the second side of the device therebyattaching a second anchor-suture/mesh to the ligament at a second site.

The suture ends are then attached to the uterine cervix fibrotic ring,the serosa of the vaginal apex, the utero-sacral ligaments, the vagina(in post hysterectomy subjects), or any other appropriate centro-apicalanchoring point of the pelvic floor as is routine for prolapseprocedures.

As is described hereinabove, the present device can also be used todeliver a mesh to the anchoring site. FIGS. 9a-h illustrate delivery ofa mesh to the anchoring site using the suture anchor implanted by thepresent device as a guide.

FIG. 9a illustrates anchor 38 positioned through the MSSL and attachedto a suture 38′.

A mesh delivery device 50 carrying mesh 52 having a distal cuff 54 (FIG.9e ) are threaded over one or both sutures 38′. Device 50 and attachedcuff 54 are advanced over suture thread(s) (FIGS. 9b-d ) by pushingdevice handle from outside the vaginal canal.

Cuff 54 is attached to the distal end of mesh 52 and is positionedaround the tip of device 50. Cuff 54 can be fabricated from an alloy orpolymer and can be configured to elastically constrict around sutures38′ when released from device 50 to fixedly attach to the sutures.Alternatively, cuff 54 can be rigid with one suture 38′ threaded throughthe cuff and the other suture 38′ around it (FIG. 9f ). In any case,when in position close to or against the MSSL, cuff 54 is released fromdevice 50 and device 50 is removed (FIG. 9g ). Sutures 38′ can then betied around cuff 54 by running a knot 56 from outside the body to cuff54 (FIG. 9h ).

The proximal end of Mesh 52 can then be secured to anchor sutures usingapproaches well known in the art.

A s used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following example, which is not intended to belimiting.

EXAMPLE

Reference is now made to the following example, which together with theabove descriptions, illustrate the invention in a non limiting fashion.

A prototype of the device described herein was used in a pelvic repairprocedure. Ten female subjects 42 to 76 years of age and havingCentro-apical prolapse, were treated using the present device and asuture-anchor or mesh-anchor implant.

Procedure

The patients were anesthetized and the present device was utilized todeliver a suture anchor with or without a mesh to the SSL after aposterior colpotomy and dissection were performed as describedhereinabove. The suture was secured with or without a mesh and aninitial pull out force was verified by manually pulling on the sutureend. The suture end were then attached to the uterine cervix fibroticring, the serosa of the vaginal apex, or the utero-sacral ligaments, thevagina (in post hysterectomy subjects), or any other appropriatecentro-apical anchoring point of the pelvic floor as is routine forprolapse procedures. Both sutures were tied while lifting prolapseduterus to its original location. The small colpotomy was then closed toend the procedure.

Two anchors were implanted in each patient (one per side). Two patientswere implanted with the suture-anchor and 8 with the suture+mesh anchor.Average procedure time was 30 minutes.

Results

The pelvic organ prolapse quantification (POP-Q) score was 3-4 prior tothe procedure. Following the procedure the POP-Q score was 0/1. Nodevice related serious adverse events (SAE) or adverse events (AE) wereobserved immediately following the procedure. A survey and examinationconducted at 3 months post operation, indicated patient satisfactionwith no device related AE or complaints from the patients and norecurrence of prolapse.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

1-21. (canceled)
 22. A surgical device comprising: an elongatecylindrical housing, adapted for mounting on a finger of a user; a rigidtube; a tissue repair implant including a tissue anchor mounted on saidrigid tube, at least one suture and a suture attachment element; and atleast one rigid guide tube attached to said housing, said at least oneguide tube being configured for guiding said tissue repair implant froma proximal opening of said at least one guide tube to a distal openingof said at least one guide tube.
 23. The device of claim 22, and whereinsaid suture attachment element is arranged to constrict around said atleast one suture to fixedly attach thereto.
 24. The device of claim 22,wherein said at least one guide tube is attached to said housing suchthat said proximal opening of said at least one guide tube protrudesbeyond a proximal end of said elongate cylindrical housing.
 25. Thedevice of claim 22, wherein said at least one guide tube is attached tosaid elongate cylindrical housing such that said proximal opening ofsaid at least one guide tube is positioned above a back of a hand ofsaid user when said elongate cylindrical housing is mounted on saidfinger of said user.
 26. The device of claim 22, wherein said elongatecylindrical housing is configured so as to enable said user to palpate atissue via said finger, to which said elongate cylindrical housing isattached.
 27. The device of claim 26, wherein said elongate cylindricalhousing includes a distal opening.
 28. The device of claim 26, whereinsaid at least one guide tube is attached to said elongate cylindricalhousing such that said distal opening of said at least one guide tubeabuts the tissue when said finger of said user contacts the tissue. 29.The device of claim 26, wherein said at least one guide tube is attachedto said elongate cylindrical housing such that said distal opening ofsaid at least one guide tube is displaced from the tissue when saidfinger of said user contacts the tissue.
 30. The device of claim 22,wherein an end of said at least one suture is attached to said tissueanchor.
 31. The device of claim 22, wherein said elongate cylindricalhousing is configured for enabling flexion of said finger at a distaland/or proximal interphalangeal joint.
 32. The device of claim 22, andalso comprising an imaging device attached to said elongate cylindricalhousing.
 33. The device of claim 32, wherein said imaging device is anultrasound transducer.
 34. The device of claim 33, wherein said elongatecylindrical housing is configured such that an imaging head of saidultrasound transducer is capable of abutting a tissue when saidultrasound transducer is attached to said elongate cylindrical housing.35. The device of claim 34, wherein said imaging head abuts said tissuewhen said finger attached to said elongate cylindrical housing contactsthe tissue.
 36. The device of claim 35, wherein the tissue is aposterior-lateral vaginal wall and said elongate cylindrical housing isconfigured for delivery into a vaginal canal via said finger.
 37. Thedevice of claim 36, wherein when said elongate cylindrical housing ispositioned within said vaginal canal with said finger in contact withsaid posterior-lateral vaginal wall, said proximal opening of said atleast one guide tube extends out of said vaginal canal.